# K012737: Chroma Zone Color Stain

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 14, 2001 after 31 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K940800 (1994). 7 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982259: Chroma Zone Color Stain, Kuraray America, Inc. (1998) Summary page 1.

## Most influential descendants
- K042929: Estenia C&B (2004), 12 descendants of its own
- K111982: Clearfil DC Core Plus (2011), 6 descendants of its own
- K142625: PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack (Universal (A2), Translucent); Automix Trial (Universal (A2), White, Translucent); Mixing tip; Endo tip (SS) (2015), 4 descendants of its own
- K063595: Clearfil Majesty Posterior (2007), 4 descendants of its own
- K150704: PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer (2015), 2 descendants of its own

## Indications for use
CHROMA ZONE COLOR STAIN is designed to be used for developing color characterization for resin-based: 1) Facing crown 2) Jacket crown 3) Inlay and Onlay

Source page: https://510kreport.com/device/K012737
Methodology: https://510kreport.com/methodology